Regulation on In Vitro Diagnostic Medical Devices - Transitional Provisions and Deferred Application
- 31/01/2022
- Articles
On 28 January 2022, the Official Journal of the EU published Regulation (EU) 2022/112 of 25 January 2022 which amends Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) by creating transitional provisions for specific in vitro diagnostic medical devices and deferring the application of conditions for in-house devices (the Regulation; see, attached copy).
The Regulation was proposed by the European Commission on 14 October 2021 in response to a widespread call for deferred application of the IVDR in view of the insufficient progress in setting up the IVDR regulatory system. In particular, market actors had become increasingly concerned about the lack of sufficient notified bodies, whose designation and work suffered additional delays as a result of the COVID-19 pandemic (see, Van Bael & Bellis Life Sciences News and Insights of 14 October 2021).
While leaving the date of application of the IVDR unchanged at 26 May 2022, the Regulation:
i. provides that devices lawfully placed on the market through a certificate issued by a notified body in accordance with the current in vitro diagnostic medical devices Directive (Directive 98/79/EC; IVDD) prior to 26 May 2022 may continue to be placed on the market or put into service until 26 May 2025. This represents an extension by one year;
ii. introduces tailored transitional periods for devices which have to undergo a conformity assessment involving notified bodies for the first time under the IVDR (but which have a declaration of conformity issued under the IVDD prior to 26 May 2022). The length of the transitional period depends on the risk class of the device concerned. Lower risk devices such as class B and class A sterile devices may be placed on the market or put into service until 26 May 2027, whereas higher risk devices (class D and class C devices) may only be placed on the market or put into service until 26 May 2025 and 26 May 2026 respectively. During these extended transitional periods, the devices must continue to comply with the IVDD. They must not have any significant changes made in their design and intended purpose;
iii. provides that devices lawfully placed on the market from 26 May 2022 pursuant to point ii. above may continue to be made available on the market, including to be supplied to end users, or put into service until 26 May 2026, 26 May 2027 and 26 May 2028 respectively, depending on the type of device concerned; and
iv. gives additional time to health institutions which manufacture devices for use within their own premises (i.e., so-called “in-house devices”) to meet the conditions set forth in Article 5, IVDR, namely until 26 May 2024 (conditions (b), (c) and (e) to (i)) and 26 May 2028 (condition (d)). The Regulation explains that this extension is justified in view of the fact that health institutions currently need their resources in the fight against the COVID-19 pandemic.
